Brainlab Navigation System Spine & Trauma 3D Recall: DrapeLink Adapters Not Made Correctly
Brainlab recalls specific DrapeLink Adapters for spine/trauma 3D systems due to manufacturing error. Affected units have unique serial numbers and model numbers. No remedy stated in recall notice.
Recall notice
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
Contact the company
What happened, in plain English
Brainlab is recalling certain DrapeLink Adapters for their Spine & Trauma 3D navigation systems because they were not made correctly due to a supplier error. This could lead to improper function during medical procedures, but the recall does not include a fix or return process. Read more at govinfonow.com/recall/72533-brainlab-navigation-system-spine-trauma-3d-recall-drapelink-adapters-not.
Source Summary by GovInfoNow · govinfonow.com/recall/72533-brainlab-navigation-system-spine-trauma-3d-recall-drapelink-adapters-not · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0320-2018
Cite this page
“Brainlab Navigation System Spine & Trauma 3D Recall: DrapeLink Adapters Not Made Correctly.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72533-brainlab-navigation-system-spine-trauma-3d-recall-drapelink-adapters-not. Based on FDA recall #Z-0320-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0320-2018%22&limit=1).
Why it’s dangerous
The adapters were not manufactured to specifications due to a supplier error, which could cause improper alignment during medical procedures. This might lead to inaccurate imaging or treatment outcomes, though the exact risk level isn't specified in the recall.
Who’s affected
Medical professionals using Brainlab's Spine & Trauma 3D systems with the specific DrapeLink Adapters mentioned in the serial numbers are likely affected. Patients receiving these procedures may be at risk if the adapters malfunction.
How to tell if you have this one
Check for serial numbers between 7459316001-7459316027 or 7714816001-7714816017. Look for model numbers 19154 or 19154-04 with the specified UDI GTIN codes.
- Brand
Brainlab- Product
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify if your adapter has a serial number in the range 7459316001-7459316027 or 7714816001-7714816017.
Where it went and when
Where it was distributed
Distributed in Kansas, and outside the U.S.
FDA distribution: “Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kansas.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0320-2018 (November 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0320-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.